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COMPLETED Phase 1

A Study of TEPEZZA Subcutaneous Administration in Healthy Adults

NCT06563856 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.

Interventions

  • DRUG TEPEZZA
  • DRUG EDP

Study Locations (1)

Nevada

  • PPD Development — Las Vegas

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2020-09-22
Est. Completion 2021-05-27
Phase Phase 1

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06563856

The ClinicalTrials.gov registry entry for NCT06563856 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Bioavailability appearing as the primary indexed condition, and to 2 interventions — of which TEPEZZA is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06563856 reports 1 study location spanning 1 distinct geographic area — top geographies include Nevada. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06563856 about?

NCT06563856 is a clinical study titled "A Study of TEPEZZA Subcutaneous Administration in Healthy Adults". The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants.

What is the current status of trial NCT06563856?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-09-22. Estimated completion is 2021-05-27.

What conditions does trial NCT06563856 study?

This clinical trial studies the following conditions: Bioavailability, Bioequivalence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06563856?

The interventions under investigation include: TEPEZZA (DRUG), EDP (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06563856?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06563856 being conducted?

This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial